Device Classification Name |
transcranial magnetic stimulation system for obsessive-compulsive disorder
|
De Novo Number |
DEN170078 |
Device Name |
Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System |
Requester |
brainways ltd. |
bynet bldg. p.o.b. 45169 |
19 hartum str. |
har hotzvim,
IL
9777518
|
|
Contact |
ahava stein |
|
Regulation Number | 882.5802
|
Classification Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 08/17/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|